Stock Market & Financial Investment News

Sarepta tumbles after FDA requests more data on drugShares of Sarepta Therapeutics (SRPT) are sinking after the company announced that the FDA had requested additional information about its eteplirsen treatment for Duchenne muscular dystrophy, or DMD. WHAT'S NEW: The FDA requested that Sarepta provide a summary explaining why dystrophin, the production of which is supposed to be stimulated by eteplirsen, is an acceptable therapy for DMD, Sarepta announced last night. The FDA also requested detailed information about the clinical trials of eteplirsen, and indicated that it would need the information in order to help determine whether the drug is eligible for accelerated approval, according to Sarepta. The company said that it was "encouraged" by its discussions with the FDA. ANALYST REACTION: In a note to clients, Piper Jaffray analyst Edward Tenthoff wrote that the FDA's request indicates that the agency is looking to find a way to grant the drug accelerated approval. There is now a greater than 50/50 chance that Sarepta will be able to file for approval of the drug based on existing data, the analyst believes, adding that such a development should cause the stock to advance significantly. If, on the other hand, Sarepta is required to conduct a Phase III clinical trial of the drug before obtaining FDA approval for it, the resulting drop in the stock will create a buying opportunity, added Tenthoff. The analyst increased his price target on the shares to $50 from $35 and reiterated an Overweight rating on the stock. TODAY'S PRICE ACTION: In mid-morning trading, Sarepta fell $5.65, or 14.4%, to $33.50.

Fujifilm CEO says 'ready' for large orders of Avigan drug for Ebola, WSJ reportsFujifilm’s (FUJIY) Avigan drug, which has shown signs of efficacy against the Ebola virus, has drawn interest from about 20 countries, The Wall Street Journal reports, citing comments made by CEO Shigetaka Komori. The drug was developed by Toyama Chemical, a Fujifilm unit, and Komori said the company is ready for large orders. Other drug companies that are working on experimental Ebola vaccines or treatments include Peregrine (PPHM), Tekmira (TKMR), Sarepta (SRPT), BioCryst (BCRX), Chimerix (CMRX) and NewLink Genetics (NLNK). Reference Link

Liberia, U.S. begin ZMapp ebola trialIn partnership with the Liberian government, the National Institute of Allergy and Infectious Diseases launched a clinical trial to obtain safety and efficacy data on the investigational drug ZMapp as a treatment for Ebola virus disease. The study may be expanded to test ZMapp against other treatments which may also include the following: Tekmira siRNA from Tekmira Pharmaceuticals (TKMR), Favipiravir from Toyama Chemical, BCX4430 from BioCryst (BCRX), and AVI-7537 from Sarepta (SRPT). The trial is expected to conclude in December 2016.

Sarepta upgraded at BofA/MerrillAs previously reported, BofA/Merrill upgraded Sarepta to Buy from Neutral. The firm has increased confidence that eleplirsen will be approved for treating boys with DMD. Price target raised to $21 from $19.